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Pink Sheet - Cell Therapies: US FDA Asked To Clarify Development Standards For Early-Phase Trials

Executive Summary

Academic institutions confused about agency standards are overly cautious in requiring early-phase studies be conducted under full GMPs, experts say; CBER Director Marks highlights regulatory flexibility but cautions that formal written guidance could be misused by those in stem cell industry.

Pink Sheet - Expanded Access: Reducing The Contract Delay

Executive Summary

While the US FDA works to cut time necessary to approve expanded access applications, sponsors are creating delays by mandating patients and institutions sign contracts to gain access.
Timetable at the Central Station

Efforts to streamline the US Food and Drug Administration's expanded access program may be hindered by legal protections that the drugs' sponsors require of prospective patients and their providers.


OncLive - Clinical Utility of Tumor Mutational Burden Remains in Flux

Although study findings have identified tumor mutational burden (TMB) as an important factor in responses to cancer therapy, establishing a definition for expression of this biomarker and harmonizing assays to measure it have proved challenging, according to Naiyer A. Rizvi, MD.


Plasma assays for determining TMB are becoming more diagnostically relevant, said Rizvi, director of thoracic oncology and immunotherapeutics at the Herbert Irving Comprehensive Cancer Center in New York, New York.


Endpoints News - Cancer research groups urge FDA to overhaul standards for early cell therapy trials, cutting time and cost. But will “pre-competitive” alliances fly?

Two in­flu­en­tial non­prof­its fo­cused on can­cer drug R&D are urg­ing the FDA to take a more flex­i­ble ap­proach to clin­i­cal work to help triage an in­flux of new cell and gene can­cer ther­a­pies mak­ing their way to hu­man stud­ies. By chang­ing cur­rent IND and man­u­fac­tur­ing stan­dards, they say, the agency can cut the time and cost of early-​stage work, ac­cel­er­at­ing the ad­vance of the most promis­ing ther­a­pies in the pipeline. 


But can they get the in­dus­try to agree on data shar­ing and pre-​competitive al­liances?


Regulatory Focus - Groups Seek More FDA Flexibility in Early Cell Therapy Development

A new white paper from the Friends of Cancer Research (FOCR) and the Parker Institute for Cancer Immunotherapy calls on the US Food and Drug Administration (FDA) to ease clinical and manufacturing requirements to speed early development of anti-cancer cell therapies.

In recent years cell therapies, including engineered T-cell receptor (TCR) and chimeric antigen receptor (CAR) T-cell therapies have shown promise in treating a wide range of cancers. To date, FDA has approved two CAR T-cell therapies to treat specific hematologic malignancies.

Bloomberg - Anxious Lawyers Hindering Cutting-Edge Drugs, Scientists Say

A risk-averse culture at universities and cancer centers holds back a field of potentially life-saving cell transplantation therapies, scientists said.


“Patients are waiting. These therapies are curative. They’re important for the field,” Ellen V. Sigal, chairperson and founder of Friends of Cancer Research, said during a May 17 meeting on the future of cell therapies.


Bloomberg Law - Fears of Slow Research Halt Federal Advisory Panel Bill

NIH concerns slammed the brakes on a bill May 15 seeking more transparency about people serving on federal advisory boards.


The Senate Homeland Security and Governmental Affairs Committee agreed to postpone voting on the Federal Advisory Committee Act (H.R. 1608) to address any negative impact on medical research.


GenomeWeb - That Paperwork, Though

The US National Institutes of Health opposes a bill wending its way through Congress aimed at making government advisory committees more transparent, Science reports.


At hand, it says, is the 1972 Federal Advisory Committee Act, which sets rules for how committee members are chosen and how meetings are run. But, it says there have been complaints for years that agencies are circumventing these rules, leading lawmakers to want to reform the act, Science adds, noting that Representative William Lacy Clay (D–Mo.) has repeatedly sponsored such a bill.


JD Supra - Checking In On FDA’s Enforcement Discretion Policy for Laboratory Developed Tests

As Congress considers comprehensive reforms to the regulatory paradigm for all in vitro clinical tests (IVCTs), including LDTs, recent developments are highlighting the limitations of FDA’s current posture of enforcement discretion.


First, FDA is sufficiently concerned about certain types of LDTs that might lack clinical evidence supporting their claims that the agency issued a warning letter to the laboratory that developed and operated the test—indicating that the agency’s policy of enforcement discretion is not absolute.

Science Magazine - NIH fears good-government bill would hamper peer review

The much-admired system to review grant proposals at the National Institutes of Health (NIH) in Bethesda, Maryland, has become the latest flashpoint in a long-running battle between Congress and the executive branch over how the U.S. government manages advisory bodies.